Potent Synthetic Corticosteroid Methylprednisolone Sodium Succinate for Injection

Model NO.: DAWAMSS0002 Usage Mode: For external use State: Solid Type: Biological Products Name: Methylprednisolone Sodium Succinate for Injection OEM: Acceptable Trademark: DAWA Specification: 40mg HS Code: 3003101200 Application: Internal Medicine Suitable for: Elderly, Children, Adult Shape: Powder Pharmaceutical Technology: Chemical Synthesis Administration Route: I.V / I.M Sample: Free Supply Transport Package: 2 Vials / Tray / Box Origin: China Potent Synthetic Corticosteroid Methylprednisolone Sodium Succinate for Injection

Uses Actions

Methylprednisolone in the form of methylprednisolone sodium succinate is a potent synthetic corticosteroid. Its anti-inflammatory potency is greater than prednisolone in the ratio of 5 to 4. It has only minimal mineralocorticoid properties and has less tendency than prednisolone to induce sodium and water retention. It influences carbohydrate, protein, fat and purine metabolism, electrolyte and water balance, and the functional capacities of the cardiovascular system, the kidney, the skeletal muscle, nervous system and other organs and tissues. It exerts a suppressive effect on the immune response.

Pharmacokinetics

Methylprednisolone sodium succinate for injection, is rapidly and extensively hydrolysed in vivo by cholinesterases to free methylprednisolone.

Indications

Methylprednisolone sodium succinate may be used in conditions in which a rapid, intense glucocorticoid effect is required.

Endocrine Disorders

•Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
•Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).
•Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.

•congenital adrenal hyperplasia.
•nonsuppurative thyroiditis.
•hypercalcaemia associated with cancer.

Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

•post-traumatic osteoarthritis

•synovitis of osteoarthritis
•rheumatoid arthritis, including juvenile
•rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
•acute and subacute bursitis
•epicondylitis
•acute non-specific tenosynovitis
•acute gouty arthritis
•psoriatic arthritis
•ankylosing spondylitis

Collagen Diseases (Immune and Complex Diseases)

During an exacerbation or as maintenance therapy in selected cases of:

•systemic lupus erythematosus (and lupus nephritis)

•acute rheumatic carditis
•systemic dermatomyositis (polymyositis)
•polyarteritis nodosa
•Good pasture's syndrome

Dermatologic Diseases

•Pemphigus
•severe erythema multiforme (Stevens-Johnson syndrome)
•exfoliative dermatitis
•bullous dermatitis herpetiformis
•severe seborrhoeic dermatitis
•severe psoriasis
•mycosis fungoides

Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:

•bronchial asthma
•contact dermatitis
•atopic dermatitis
•serum sickness
•seasonal or perennial allergic rhinitis
•drug hypersensitivity reactions
•urticarial transfusion reactions
•acute non-infectious laryngeal oedema (epinephrine is the drug of first choice)
•Severe hypersensitivity reactions. In life threatening situations such as anaphylactic reactions, adrenaline should be administered first to achieve an immediate haemodynamic effect. This may be followed by an intravenous injection of methylprednisolone sodium succinate and other accepted procedures.

Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

•herpes zoster ophthalmicus
•iritis, iridocyclitis
•chorioretinitis
•diffuse posterior uveitis and choroiditis
•optic neuritis
•sympathetic ophthalmia
•anterior segment inflammation
•allergic conjunctivitis
•allergic corneal marginal ulcers
•keratitis

Gastrointestinal Diseases

To tide the patient over a critical period of the disease in -

•ulcerative colitis (systemic therapy) or Crohn's disease
•regional enteritis (systemic therapy)

Respiratory Diseases

•symptomatic sarcoidosis
•berylliosis
•fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy

•Loeffler's Syndrome not manageable by other means
•aspiration pneumonitis
•Status asthmaticus
•Methylprednisolone is beneficial as adjunctive therapy in the treatment of Aids patients with moderate to severe pneumocystis carinii pneumonia when given in the first 72 hours of initial anti-pneumocystis treatment. Due to the increased rate of reactivation of tuberculosis in Aids patients, consideration should be given to the administration of anti-mycobacteria therapy if corticosteroids are used in this high risk group. The patient should also be observed for activation of other latent infections.
Haematologic Disorders

•acquired (autoimmune) haemolytic anaemia

•idiopathic thrombocytopaenia purpura in adults (IV only; IM administration is contraindicated)
•secondary thrombocytopaenia in adults
•erythroblastopenia (RBC anaemia)
•congenital (erythroid) hypoplastic anaemia

Neoplastic Diseases

For palliative management of:

•leukaemias and lymphomas in adults

•acute leukaemia of childhood

Terminal Cancer

•To improve quality of life in patients with terminal cancer.

Oedematous States

•To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.

Nervous System

•Cerebral oedema from tumour - primary or metastatic and/or associated with surgical or radiation therapy.

•Acute exacerbations of multiple sclerosis.
•Acute spinal chord injury. The treatment should begin within eight hours of injury.

Cardiovascular Conditions

•Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present. (Hydrocortisone is generally the drug of choice. When mineralocorticoid activity is undesirable, methylprednisolone may be preferred.)

Although there are no well controlled (double-blind placebo) clinical trials, data from experimental animal models indicate that methylprednisolone may be useful in haemorrhagic, traumatic and surgical shock in which standard therapy (eg. fluid replacement, etc.) has not been effective.

The adjunctive use of intravenous methylprednisolone sodium succinate in severe shock may assist in achieving haemodynamic restoration. Corticosteroid therapy should not replace standard methods of combating shock.

Organ Transplantation

•Suppression of graft rejection reactions following transplantation, as part of a treatment regime.

Miscellaneous

•Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

•Trichinosis with neurologic or myocardial involvement.
•Prevention of nausea and vomiting associated with cancer chemotherapy.

NB: Methylprednisolone sodium succinate should principally be used for short-term emergency treatment.

Dosage and Administration

After reconstitution, Methylprednisolone Sodium Succinate for Injection may be given by intravenous or intramuscular injection or by intravenous infusion (intermittent or continuous). For initial emergency use, direct IV push or intermittent infusion is the preferred method. Methylprednisolone Sodium Succinate for Injection is not indicated for intrathecal, epidural or local injection.

As adjunctive therapy in life threatening conditions (e.g. shock states) the recommended dose of Methylprednisolone is 30 milligrams per kg of methylprednisolone sodium succinate, given IV over a period of at least 30 minutes. This dose may be repeated every 4 to 6 hours for up to 48 hours.
Pulse dosing for corticosteroid responsive diseases in exacerbation and/or unresponsive to standard therapy (eg. lupus nephritis, rheumatoid arthritis, etc.). Suggested schedules -
 
Rheumatic disorders: 1 gm/day for one, two, three or four days IV or 1 gm/month for six months IV. 
Systemic lupus erythematosus: 1 gm/day for three days IV.
Multiple sclerosis: 1 gm/day for three days IV or 1 gm/day for five days IV.
Oedematous states e.g. glomerulonephritis, lupus nephritis: 30 mg/kg every other day for four days IV or 1 gm/day for three, five or seven days IV. 
The regimen should be administered over at least 30 minutes, and may be repeated if improvement has not occurred within a week after therapy or as patient's condition dictates.

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